Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) Novel Proximal Pathways for Non ST Elevation Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 601
- 试验地点
- 5
- 主要终点
- Time from first medical contact to final patient disposition.
研究概览
简要总结
The purpose of this study is to determine if early diagnosis and risk stratification acquired through pre-hospital clinical assessment, 12-lead electrocardiogram and point of care biomarkers will facilitate enhanced triage and treatment in patients with presumed non-ST elevation acute coronary syndromes (NSTEMI).
详细描述
Utilizing the platform of pre-hospital STEMI research and clinical experience developed over the past decade; we now intend to investigate how best to achieve timely diagnosis and risk stratification of patients that present to pre-hospital emergency medical services with symptoms suspicious for acute NSTEMI through utilization of systematic clinical assessment, pre-hospital 12 lead electrocardiogram and point of care measurement of biomarkers. Additionally, where deemed appropriate these patients will be enrolled in a clinical Chest Pain Protocol utilizing the pre-hospital biomarkers. We hypothesize that establishing a pre-hospital diagnosis in this condition may facilitate efficient triage and -as appropriate- in-hospital disposition. Additionally, the enhanced pre-hospital assessment of this population will facilitate appropriate timely disposition of those patients not found to have acute cardiovascular disease. These processes will facilitate decanting the frequently overcrowded and under resources Emergency Departments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 31 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient that activates pre-hospital Emergency Medical Services (EMS) for symptoms of acute chest discomfort for which acute cardiovascular disease is deemed to be the most probable diagnosis by EMS personnel.
- •Patient is older than 30 years of age
- •Patient is able to give informed consent
排除标准
- •Patient with documented ST elevation on the initial 12 lead ECG
- •Patient with a prior diagnosis that is compatible with another disease i.e. severe asthma, etc.
- •Patient with Central Nervous System symptoms or syncope
- •Patient with cardiac arrest, ventricular tachycardia or atrial fibrillation with heart rate > 110 bpm
研究组 & 干预措施
Group 1 - no pre-hospital biomarkers
Standard of Care
Group 2 - pre-hospital biomarkers
Troponin and BNP measured on a POC meter in the ambulance on the way to the hospital.
干预措施: Alere Triage Meter Pro (Device)
结局指标
主要结局
Time from first medical contact to final patient disposition.
时间窗: From date of first medical contact until first appropriate therapy given, assessed up to 30 months
An Adjudication Committee will examine the records to determine final diagnosis. Final patient disposition is defined as the time when a plan for patient discharge from the ED or admission to hospital is both established and documented.
次要结局
- 30-day all-cause mortality(Assessed up to 30 months)
- Time to administration of appropriate evidence based therapy(Assessed up to 30 months.)
- Length of hospital stay for patients admitted to hospital(Assessed up to 30 months)
- In-hospital clinical events (day 7 or discharge) all-cause mortality, cardiogenic shock, heart failure, re-Myocardial infarction(Assessed up to 30 months)
- 30 day all-cause hospitalization or re-hospitalization(Assessed up to 30 months)
- 30-day composite (all-cause mortality or all-cause hospitalization)(Assessed up to 30 months)
研究者
Robert Welsh
Principal Investigator
University of Alberta